Methods for treating closed angle glaucoma

ABSTRACT

The present invention generally relates to methods for treating closed angle glaucoma. In certain embodiments, methods of the invention involve inserting into an eye a deployment device configured to hold an intraocular shunt, using the device to re-open an at least partially closed anterior chamber angle of an eye, and deploying the shunt from the device.

FIELD OF THE INVENTION

The present invention generally relates to methods for treating closedangle glaucoma.

BACKGROUND

Glaucoma is a disease of the eye that affects millions of people.Glaucoma is associated with an increase in intraocular pressureresulting either from a failure of a drainage system of an eye toadequately remove aqueous humor from an anterior chamber of the eye oroverproduction of aqueous humor by a ciliary body in the eye. Build-upof aqueous humor and resulting intraocular pressure may result inirreversible damage to the optic nerve and the retina, which may lead toirreversible retinal damage and blindness.

There are two main types of glaucoma, “open angle” and “closed angle”glaucoma. Open angle glaucoma refers to glaucoma cases in whichintraocular pressure increases but an anterior chamber angle (drainageangle) of an eye remains open. A common cause of open angle glaucoma isblockage in the trabecular meshwork, the fluid flow pathways thatnormally drain aqueous humor from the anterior chamber of the eye.Closed angle glaucoma refers to glaucoma cases in which intraocularpressure increases due to partial or complete closure of the anteriorchamber angle. In closed angle glaucoma, swelling or movement of theiris closes the anterior chamber angle and blocks fluid from accessingto the trabecular meshwork, which in turn obstructs outflow of theaqueous humor from the eye.

Generally, glaucoma may be treated by surgical intervention thatinvolves placing a shunt in the eye to result in production of fluidflow pathways between the anterior chamber and various structures of theeye involved in aqueous humor drainage (e.g., Schlemm's canal or thesubconjunctival space). Such fluid flow pathways allow for aqueous humorto exit the anterior chamber. Generally, the surgical intervention toimplant the shunt involves inserting into the eye a deployment devicethat holds an intraocular shunt, and deploying the shunt from the deviceand into the eye. A deployment device holding the shunt enters the eyethrough a cornea (ab interno approach), and is advanced across theanterior chamber. The deployment device is advanced into the anteriorchamber angle and through the sclera until a distal portion of thedevice is in proximity to a drainage structure of the eye. The shunt isthen deployed from the deployment device, producing a conduit betweenthe anterior chamber and various structures of the eye involved inaqueous humor drainage (e.g., Schlemm's canal, the sclera, or thesubconjunctival space). See for example, Yu et al. (U.S. Pat. No.6,544,249 and U.S. patent application number 2008/0108933) and Prywes(U.S. Pat. No. 6,007,511).

SUMMARY

A problem with treating closed angle glaucoma with surgical interventionis that the closed anterior chamber angle prevents an operator fromadvancing the deployment device into the anterior chamber angle, andthus the device cannot be properly positioned to deploy an intraocularshunt.

The present invention generally relates to methods for treating closedangle glaucoma that involve using a deployment device that is configuredto both re-open a partially or completely closed anterior chamber angleand deploy an intraocular shunt. By re-opening the anterior chamberangle, the deployment device is provided access to the anterior chamberangle so that an operator may properly position the device to deploy theintraocular shunt, thereby generating a fluid flow pathway for outflowof aqueous humor from an anterior chamber of an eye.

In certain aspects, methods of the invention involve inserting into aneye a deployment device configured to hold an intraocular shunt, usingthe device to re-open an at least partially closed anterior chamberangle of an eye, and deploying the shunt from the device. Deploying theshunt results in a flow path from an anterior chamber of the eye to anarea of lower pressure. Exemplary areas of lower pressure includeintra-Tenon's space, the subconjunctival space, the episcleral vein, thesuprachoroidal space, and Schlemm's canal. In certain embodiments, thearea of lower pressure is the subarachnoid space.

In other aspects, methods of the invention involve inserting into an eyea deployment device configured to hold an intraocular shunt, advancingthe device such that a protrusion on a distal end of the device advancesinto an at least partially closed anterior chamber angle of the eye,thereby re-opening the closed angle, and deploying the shunt from thedevice. In certain embodiments, a distal portion of the device includesa sleeve and a hollow shaft that is movable within the sleeve. Incertain embodiments, the protrusion may be formed integrally with thedistal end of the sleeve or may be connected to a distal end of thesleeve. In certain embodiments, the protrusion may surround the distalend of the sleeve, or the protrusion may extend around only a portion ofthe sleeve. In certain embodiments, the protrusion is a collar thatsurrounds the distal end of the sleeve. In other embodiments, theprotrusion includes a flat bottom portion and an angled top portion. Inparticular embodiments, the angle of the top portion is substantiallyidentical to an anterior chamber angle of an eye.

Methods of the invention are typically conducted using an ab internoapproach. Such an approach is contrasted with an ab externo approach,which involves inserting a deployment device through the conjunctiva ofthe eye. Although, methods of the invention may be conducted using an abexterno approach.

Methods of the invention may be performed such that the distal portionof the deployment device is inserted above or below the corneal limbus.Methods of the invention may be performed such that the distal portionof the deployment device is inserted into the eye without removing ananatomical feature of the eye, such as the trabecular meshwork, theiris, the cornea, and the aqueous humor. In certain embodiments, methodsof the invention may be conducted without substantial subconjunctivalblebbing. In particular embodiments, methods of the invention areperformed without the use of an optical apparatus that contacts the eye,such as a goniolens.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic showing an embodiment of a shunt deploymentdevice according to the invention. FIG. 1B shows a cross sectional viewof the device of FIG. 1. In this figure, the distal portion of thehousing is extended from the proximal portion of the housing. FIG. 1Cshows a cross sectional view of the device of FIG. 1. In this figure,the distal portion of the housing is retracted within the proximalportion of the housing. FIG. 1D is a schematic showing an enlarged viewof a protrusion on a distal end of a distal portion of a housing of thedevice of FIG. 1A. In this figure, a bottom portion of the protrusion isflat and a top portion of the protrusion is angled.

FIGS. 2A-2C are schematics showing an enlarged view of a protrusion on adistal end of a distal portion of a housing of devices of the invention.FIG. 2B is a side view of the protrusion shown in FIG. 2A. FIG. 2C is atop view of the protrusion shown in FIG. 2A.

FIG. 3 shows an exploded view of the device shown in FIG. 1.

FIGS. 4A to 4D are schematics showing different enlarged views of thedeployment mechanism of the deployment device.

FIGS. 5A to 5C are schematics showing interaction of the deploymentmechanism with a portion of the housing of the deployment device.

FIG. 6 depicts a schematic of an exemplary intraocular shunt.

FIG. 7 shows a cross sectional view of the deployment mechanism of thedeployment device.

FIG. 8A is a schematic showing deployment devices of the invention in apre-deployment or insertion configuration. FIG. 8B shows an enlargedview of the distal portion of the deployment device of FIG. 8A. Thisfigure shows an intraocular shunt loaded within a hollow shaft of thedeployment device and that the shaft is completely disposed within thesleeve of the housing. FIG. 8C show a schematic of the deploymentmechanism in a pre-deployment or insertion configuration. FIG. 8D isanother schematic showing deployment devices of the invention in apre-deployment or insertion configuration.

FIG. 9 is a schematic showing insertion of a device of the inventioninto an anterior chamber of the eye. This figure also shows the sleeveand protrusion fitted within an anterior chamber angle of the eye.

FIG. 10 is a schematic showing extension of the shaft from within thesleeve, which is accomplished by partial retraction of the distalportion of housing to within the proximal portion of housing.

FIGS. 11A and 11B show schematics of the deployment mechanism at the endof the first stage of deployment of the shunt from the deploymentdevice. FIG. 11C shows an enlarged view of the distal portion of thedeployment device of FIG. 11A. This figure shows an intraocular shuntpartially deployed from within a hollow shaft of the deployment device.

FIG. 12 is a schematic showing the deployment device after completion ofthe first stage of deployment of the shunt from the device and in to theeye.

FIG. 13A show a schematic of the deployment mechanism at the end of thesecond stage of deployment. FIG. 13B shows a schematic of the deploymentdevice at the end of the second stage of deployment. FIG. 13C showsanother view of the deployment device at the end of the second stage ofdeployment.

FIG. 14 is a schematic showing the deployment device after completion ofdeployment of the shunt from the device and in to the eye.

DETAILED DESCRIPTION

The present invention generally relates to methods for treating closedangle glaucoma that involve using a deployment device that is configuredto both re-open a partially or completely closed anterior chamber angleand deploy an intraocular shunt. In certain aspects, methods of theinvention involve inserting into an eye a deployment device configuredto hold an intraocular shunt, using the device to re-open an at leastpartially closed anterior chamber angle of an eye, and deploying theshunt from the device.

Reference is now made to FIG. 1A which shows an embodiment of a shuntdeployment device 100 that may be used to re-open a partially orcompletely closed anterior chamber angle and deploy an intraocularshunt. While FIG. 1 shows a handheld manually operated shunt deploymentdevice, it will be appreciated that devices of the invention may becoupled with robotic systems and may be completely or partiallyautomated. As shown in FIG. 1A deployment device 100 includes agenerally cylindrical body or housing 101, however, the body shape ofhousing 101 could be other than cylindrical. Housing 101 may have anergonomical shape, allowing for comfortable grasping by an operator.Housing 101 is shown with optional grooves 102 to allow for easiergripping by a surgeon.

FIG. 1B shows a cross sectional view of device 100. This figure showsthat housing 101 includes a proximal portion 101 a and a distal portion101 b. The distal portion 101 b is movable within proximal portion 101a. In this figure, spring mechanism 120 includes a spring 121 thatcontrols movement of distal portion 101 b. Spring mechanism 120 furtherincludes a member 122 that acts as a stopper and limits axial retractionof distal portion 101 b within proximal portion 101 a. Spring mechanism120 further includes members 123 and 124 that run the length of spring121. The ends of members 123 and 124 include flanges 125 and 126 thatproject inward from members 123 and 124. An end of distal portion 101 bincludes flanges 127 and 128 that project outward from distal portion101 b. Flanges 125 and 126 interact with flanges 127 and 128 to preventrelease of distal portion 101 b from proximal portion 101 a. The flanges125 and 126 and 127 and 128 hold the distal portion 101 b in an extendedposition until a compressive force acts upon distal portion 101 b,thereby causing distal portion 101 b to partially retract withinproximal portion 101 a.

Distal portion 101 b includes a capsule 129 and a hollow sleeve 130.Capsule 129 and sleeve 130 may be formed integrally or may be separatecomponents that are coupled or connected to each other. The hollowsleeve 130 is configured for insertion into an eye and to extend into ananterior chamber of an eye. FIG. 1B shows distal portion 101 b ofhousing 101 extended from proximal portion 101 a of housing 101. In thisconfiguration, hollow shaft 104 (not shown in this figure) is completelydisposed within sleeve 130. FIG. 1C shows distal portion 101 b ofhousing 101 retracted within proximal portion 101 a of housing 101.Retraction of distal portion 101 b of housing 101 within proximalportion 101 a of housing 101 exposes hollow shaft 104, which isdiscussed in greater detail below.

A distal end of sleeve 130 includes a protrusion 131 (FIG. 1D).Protrusion 131 is of a shape and size that it is capable of re-opening apartially or completely closed anterior chamber angle of an eye as anoperator is advancing the device 100 through an anterior chamber of aneye. In a standard ab interno approach (see for example Yu et al. U.S.Pat. No. 6,544,249 and U.S. patent application number. 2008/0108933) adeployment device holding a shunt enters an eye through a cornea. Thedeployment device is advanced across the anterior chamber in what isreferred to as a transpupil implant insertion. The deployment device isadvanced into the anterior chamber angle on the opposite side of the eyefrom which the device entered the eye. With devices of the invention,upon advancement of the device 100 across an anterior chamber of theeye, the protrusion 131 at the distal end of the hollow sleeve 130 willcontact a partially or completely closed anterior chamber angle, andcontinued advancement of the device 100 will result in the protrusion131 re-opening the partially or completely closed anterior chamberangle. Once re-opened by the protrusion 131, the device 100 can be movedinto proper position for exposure of the hollow shaft 104, which willadvance through the sclera for deployment of an intraocular shunt. Theprotrusion 131, provides adequate surface area at the distal end ofsleeve 130, thus preventing sleeve 130 from entering the tissue of theeye that is blocking access the trabecular meshwork (e.g., the iris).

In certain embodiments, protrusion 131 has a substantially flat bottomportion and an angled top portion (FIG. 1D). In other embodiments,protrusion 131 has a slightly tapered top and a slightly tapered bottomwith a rounded distal portion (FIGS. 2A-2C). Referring back to FIG. 1D,the angle of the top portion is substantially identical to an anteriorchamber angle of an eye. Such a shape of the protrusion ensures that thedevice of the invention will conform and easily slide into the anteriorchamber angle of the eye, the place for proper deployment of anintraocular shunt.

Referring back to FIG. 1A, the proximal portion 101 a of the housing 101is open at its proximal end, such that a portion of a deploymentmechanism 103 may extend from the proximal end of the proximal portion101 a of the housing 101. The sleeve 130 of the distal portion 101 b ofthe housing 101 is also open such that at least a portion of a hollowshaft 104 may extend inside the housing, into sleeve 130 of the distalportion 101 b of the housing 101, and extend beyond the distal end ofthe sleeve 130 in certain configurations (such as the deploymentconfiguration). Housing 101 further includes a slot 106 through which anoperator, such as a surgeon, using the device 100 may view an indicator107 on the deployment mechanism 103.

Housing 101 and protrusion 131 may be made of any material that issuitable for use in medical devices. For example, housing 101 andprotrusion 131 may be made of a lightweight aluminum or a biocompatibleplastic material. Examples of such suitable plastic materials includepolycarbonate and other polymeric resins such as DELRIN and ULTEM. Incertain embodiments, housing 101 and protrusion 131 are made of amaterial that may be autoclaved, and thus allow for housing 101 andprotrusion 131 to be re-usable. Alternatively, device 100, may be soldas a one-time-use device, and thus the material of the housing and theprotrusion does not need to be a material that is autoclavable.

The proximal portion 101 a of housing 101 may be made of multiplecomponents that connect together to form the housing. FIG. 4 shows anexploded view of deployment device 100. In this figure, proximal portion101 a of housing 101, is shown having two components 101 a 1 and 101 a2. The components are designed to screw together to form proximalportion 101 a of housing 101. FIG. 4 also shows deployment mechanism103. The housing 101 is designed such that deployment mechanism 103 fitswithin assembled housing 101. Housing 101 is designed such thatcomponents of deployment mechanism 103 are movable within housing 101.

FIGS. 4A to 4D show different enlarged views of the deployment mechanism103. Deployment mechanism 103 may be made of any material that issuitable for use in medical devices. For example, deployment mechanism103 may be made of a lightweight aluminum or a biocompatible plasticmaterial. Examples of such suitable plastic materials includepolycarbonate and other polymeric resins such as DELRIN and ULTEM. Incertain embodiments, deployment mechanism 103 is made of a material thatmay be autoclaved, and thus allow for deployment mechanism 103 to bere-usable. Alternatively, device 100 may be sold as a one-time-usedevice, and thus the material of the deployment mechanism does not needto be a material that is autoclavable.

Deployment mechanism 103 includes a proximal portion 109 and a distalportion 110. The deployment mechanism 103 is configured such thatproximal portion 109 is movable within distal portion 110. Moreparticularly, proximal portion 109 is capable of partially retracting towithin distal portion 110.

In this embodiment, the proximal portion 109 is shown to taper to aconnection with a hollow shaft 104. This embodiment is illustrated suchthat the connection between the hollow shaft 104 and the proximalportion 109 of the deployment mechanism 103 occurs inside the housing101. Hollow shaft 104 may be removable from the proximal portion 109 ofthe deployment mechanism 103. Alternatively, the hollow shaft 104 may bepermanently coupled to the proximal portion 109 of the deploymentmechanism 103.

Generally, hollow shaft 104 is configured to hold an intraocular shunt115. An exemplary intraocular shunt 115 in shown in FIG. 6. Otherexemplary intraocular shunts are shown in Yu et al. (U.S. patentapplication number 2008/0108933). Generally, in one embodiment,intraocular shunts are of a cylindrical shape and have an outsidecylindrical wall and a hollow interior. The shunt may have an innerdiameter of approximately 50 μm to approximately 250 μm, an outsidediameter of approximately 190 μm to approximately 300 μm, and a lengthof approximately 0.5 mm to about 20 mm. Thus, hollow shaft 104 isconfigured to at least hold a shunt of such shape and such dimensions.However, hollow shaft 104 may be configured to hold shunts of differentshapes and different dimensions than those described above, and theinvention encompasses a shaft 104 that may be configured to hold anyshaped or dimensioned intraocular shunt. In particular embodiments, theshaft has an inner diameter of approximately 200 μm to approximately 400μm.

The shaft 104 may be any length. A usable length of the shaft may beanywhere from about 5 mm to about 40 mm, and is 15 mm in certainembodiments. In certain embodiments, the shaft is straight. In otherembodiments, shaft 104 is of a shape other than straight, for example ashaft having a bend along its length or a shaft having an arcuateportion. Exemplary shaped shafts are shown for example in Yu et al.(U.S. patent application number 2008/0108933). In particularembodiments, the shaft includes a bend at a distal portion of the shaft.In other embodiments, a distal end of the shaft is beveled or issharpened to a point.

The shaft 104 may hold the shunt at least partially within the hollowinterior of the shaft 104. In other embodiments, the shunt is heldcompletely within the hollow interior of the shaft 104. Alternatively,the hollow shaft may hold the shunt on an outer surface of the shaft104. In particular embodiments, the shunt is held within the hollowinterior of the shaft 104. In certain embodiments, the hollow shaft is aneedle having a hollow interior. Needles that are configured to hold anintraocular shunt are commercially available from Terumo Medical Corp.(Elkington, Md.).

A distal portion of the deployment mechanism 103 includes optionalgrooves 116 to allow for easier gripping by an operator for easierrotation of the deployment mechanism, which will be discussed in moredetail below. The distal portion 110 of the deployment mechanism alsoincludes at least one indicator that provides feedback to an operator asto the state of the deployment mechanism. The indicator may be any typeof indicator know in the art, for example a visual indicator, an audioindicator, or a tactile indicator. FIG. 4 shows a deployment mechanismhaving two indicators, a ready indicator 111 and a deployed indicator119. Ready indicator 111 provides feedback to an operator that thedeployment mechanism is in a configuration for deployment of anintraocular shunt from the deployment device 100. The indicator 111 isshown in this embodiment as a green oval having a triangle within theoval. Deployed indicator 119 provides feedback to the operator that thedeployment mechanism has been fully engaged and has deployed the shuntfrom the deployment device 100. The deployed indicator 119 is shown inthis embodiment as a yellow oval having a black square within the oval.The indicators are located on the deployment mechanism such that whenassembled, the indicators 111 and 119 may be seen through slot 106 inhousing 101.

The distal portion 110 includes a stationary portion 110 b and arotating portion 110 a. The distal portion 110 includes a channel 112that runs part of the length of stationary portion 110 b and the entirelength of rotating portion 110 a. The channel 112 is configured tointeract with a protrusion 117 on an interior portion of housingcomponent 101 a (FIGS. 5A and 5B). During assembly, the protrusion 117on housing component 101 a 1 is aligned with channel 112 on thestationary portion 110 b and rotating portion 110 a of the deploymentmechanism 103. The distal portion 110 of deployment mechanism 103 isslid within housing component 101 a 1 until the protrusion 117 sitswithin stationary portion 110 b (FIG. 5C). Assembled, the protrusion 117interacts with the stationary portion 110 b of the deployment mechanism103 and prevents rotation of stationary portion 110 b. In thisconfiguration, rotating portion 110 a is free to rotate within housingcomponent 101 a 1.

Referring back to FIG. 4, the rotating portion 110 a of distal portion110 of deployment mechanism 103 also includes channels 113 a, 113 b, and113 c. Channel 113 a includes a first portion 113 a 1 that is straightand runs perpendicular to the length of the rotating portion 110 a, anda second portion 113 a 2 that runs diagonally along the length ofrotating portion 110 a, downwardly toward a distal end of the deploymentmechanism 103. Channel 113 b includes a first portion 113 b 1 that runsdiagonally along the length of the rotating portion 110 a, upwardlytoward a proximal end of the deployment mechanism 103, and a secondportion that is straight and runs perpendicular to the length of therotating portion 110 a. The point at which first portion 113 a 1transitions to second portion 113 a 2 along channel 113 a, is the sameas the point at which first portion 113 b 1 transitions to secondportion 113 b 2 along channel 113 b. Channel 113 c is straight and runsperpendicular to the length of the rotating portion 110 a. Within eachof channels 113 a, 113 b, and 113 c, sit members 114 a, 114 b, and 114 crespectively. Members 114 a, 114 b, and 114 c are movable withinchannels 113 a, 113 b, and 113 c. Members 114 a, 114 b, and 114 c alsoact as stoppers that limit movement of rotating portion 110 a, whichthereby limits axial movement of the shaft 104.

FIG. 7 shows a cross-sectional view of deployment mechanism 103. Member114 a is connected to the proximal portion 109 of the deploymentmechanism 103. Movement of member 114 a results in retraction of theproximal portion 109 of the deployment mechanism 103 to within thedistal portion 110 of the deployment mechanism 103. Member 114 b isconnected to a pusher component 118. The pusher component 118 extendsthrough the proximal portion 109 of the deployment mechanism 103 andextends into a portion of hollow shaft 104. The pusher component isinvolved in deployment of a shunt from the hollow shaft 104. Anexemplary pusher component is a plunger. Movement of member 114 bengages pusher 118 and results in pusher 118 advancing within hollowshaft 104.

Reference is now made to FIGS. 8-14, which accompany the followingdiscussion regarding deployment of a shunt 115 from deployment device100. FIG. 8A shows deployment device 100 is a pre-deployment orinsertion configuration. In this configuration, shunt 115 is loadedwithin hollow shaft 104 (FIG. 8B). As shown in FIG. 8B, shunt 115 isonly partially within shaft 104, such that a portion of the shunt isexposed. However, the shunt 115 does not extend beyond the end of theshaft 104. In other embodiments, the shunt 115 is completely disposedwithin hollow shaft 104. The shunt 115 is loaded into hollow shaft 104such that the shunt abuts pusher component 118 within hollow shaft 104.

In the pre-deployment or insertion configuration, the distal portion 101b of the housing 101 is in an extended position, with spring 121 in arelaxed state (FIG. 8A). Additionally, in the pre-deploymentconfiguration, the shaft 104 is fully disposed within the sleeve 130 ofthe distal portion 101 b of the housing 101 (FIG. 8B). Pusher 118 abutsshunt 115 (FIG. 8B).

The deployment mechanism 103 is configured such that member 114 a abutsa proximal end of the first portion 113 a 1 of channel 113 a, and member114 b abut a proximal end of the first portion 113 b 1 of channel 113 b(FIG. 8C). In this configuration, the ready indicator 111 is visiblethrough slot 106 of the housing 101, providing feedback to an operatorthat the deployment mechanism is in a configuration for deployment of anintraocular shunt from the deployment device 100 (FIG. 8D). In thisconfiguration, the device 100 is ready for insertion into an eye(insertion configuration or pre-deployment configuration).

FIG. 9 shows device 100 in the insertion configuration and inserted intoan eye 140. Any of a variety of methods known in the art may be used toinsert devices of the invention into an eye. In certain embodiments,devices of the invention may be inserted into the eye using an abexterno approach (entering through the conjunctiva) or an ab internoapproach (entering through the cornea). In particular embodiment, theapproach is an ab interno approach as shown Yu et al. (U.S. Pat. No.6,544,249 and U.S. patent application number 2008/0108933) and Prywes(U.S. Pat. No. 6,007,511), the content of each of which is incorporatedby reference herein in its entirety.

FIG. 9 shows an ab interno approach for insertion of device 100 into theeye 140. In this figure, protrusion 131 at the distal end of the sleeve130 has been advanced across the anterior chamber 141 to the anteriorchamber angle 143 on the opposite side of the eye 140 from which thedevice entered the eye 140. FIG. 9 shows protrusion 131 and sleeve 130fitted within the anterior chamber angle 143 of the eye 140, thusre-opening the partially or completely closed anterior chamber angle143.

In certain embodiments, such insertion and placement is accomplishedwithout the use of an optical apparatus that contacts the eye, such as agoniolens. In certain embodiments this insertion is accomplished withoutthe use of any optical apparatus. Insertion without the use of anoptical apparatus that contacts the eye, or any optical apparatus, ispossible because of various features of the device described discussedherein. The shape of the protrusion 131 is such that it corrects for aninsertion angle that is too steep or too shallow, ensuring that thesleeve 130 is fitted into the anterior chamber angle of the eye, theplace for proper deployment of an intraocular shunt. Further, the shapeof the protrusion provides adequate surface area at the distal end ofsleeve 130 to prevent enough force from being generated at the distalend of sleeve 130 that would result in sleeve 130 entering an improperportion of the sclera 142 (if the insertion angle is too shallow) orentering an improper portion of the iris 144 (if the insertion angle istoo steep). Additionally, since the shaft 104 is fully disposed withinthe sleeve 130, it cannot piece tissue of the eye until it is extendedfrom the sleeve 130. Thus, if the insertion angle is too shallow or toosteep, the protrusion 131 can cause movement and repositioning of thesleeve 130 so that the sleeve 130 is properly positioned to fit in theanterior chamber angle of the eye for proper deployment of the shunt.Due to these features of device 100, devices of the invention providefor deploying intraocular shunts without use of an optical apparatusthat contacts the eye, preferably without use of any optical apparatus.

Once the device has been inserted into the eye and the protrusion 131and the sleeve 130 are fitted within the anterior chamber angle of theeye, the hollow shaft 104 may be extended from within the sleeve 130.Referring now to FIG. 10 which shows extension of the shaft 104 fromwithin the sleeve 130, which is accomplished by partial retraction ofdistal portion 101 b of housing 101 to within proximal portion 101 a ofhousing 101.

Retraction of the distal portion 101 b of housing 101 to within proximalportion 101 a of housing 101 is accomplished by an operator continuingto apply force to advance device 100 after the protrusion 131 and thesleeve 130 are fitted within the anterior chamber angle of the eye. Thesurface area of protrusion 131 prevents the application of theadditional force by the operator from advancing sleeve 130 into thesclera 134. Rather, the additional force applied by the operator resultsin engagement of spring mechanism 120 and compression of spring 121within spring mechanism 120. Compression of spring 120 results inretraction of distal portion 101 b of housing 101 to within proximalportion 101 a of housing 101. The amount of retraction of distal portion101 b of housing 101 to within proximal portion 101 a of housing 101 islimited by member 122 that acts as a stopper and limits axial retractionof distal portion 101 b within proximal portion 101 a.

Retraction of distal portion 101 b of housing 101 to within proximalportion 101 a of housing 101 results in extension of hollow shaft 104,which now extends beyond the distal end of sleeve 130 and advancesthrough the sclera 142 to an area of lower pressure than the anteriorchamber. Exemplary areas of lower pressure include Schlemm's canal, thesubconjunctival space, the episcleral vein, the suprachoroidal space, orthe intra-Tenon's space.

In this figure, a distal end of the shaft is shown to be located withinthe intra-Tenon's space. Within an eye, there is a membrane known as theconjunctiva, and the region below the conjunctiva is known as thesubconjunctival space. Within the subconjunctival space is a membraneknown as Tenon's capsule. Below Tenon's capsule there are Tenon'sadhesions that connect the Tenon's capsule to the sclera. The spacebetween Tenon's capsule and the sclera where the Tenon's adhesionsconnect the Tenon's capsule to the sclera is known as the intra-Tenon'sspace. This figure is exemplary and depicts only one embodiment for alocation of lower pressure. It will be appreciated that devices of theinvention may deploy shunts to various different locations of the eyeand are not limited to deploying shunts to the intra-Tenon's space isshown by way of example in this figure. In this configuration, the shunt115 is still completely disposed within the shaft 104.

The distal end of shaft 104 may be beveled to assist in piercing thesclera and advancing the distal end of the shaft 104 through the sclera.In this figure, the distal end of the shaft 104 is shown to have adouble bevel (See also FIG. 8B). The double bevel provides an angle atthe distal end of the shaft 104 such that upon entry of the shaft intointra-Tenon's space, the distal end of shaft 104 will by parallel withTenon's capsule and will thus not pierce Tenon's capsule and enter thesubconjunctival space. This ensures proper deployment of the shunt suchthat a distal end of the shunt 115 is deployed within the intra-Tenon'sspace, rather than deployment of the distal end of the shunt 115 withinthe subconjunctival space. Changing the angle of the bevel allows forplacement of shunt 115 within other areas of lower pressure than theanterior chamber, such as the subconjunctival space. It will beunderstood that FIG. 11 is merely one embodiment of where shunt 115 maybe placed within the eye, and that devices of the invention are notlimited to placing shunts within intra-Tenon's space and may be used toplace shunts into many other areas of the eye, such as Schlemm's canal,the subconjunctival space, the episcleral vein, or the suprachoroidalspace.

Reference is now made to FIGS. 11A to 11C. After extension of hollowshaft 104 from sleeve 130, the shunt 115 may be deployed from the device100. The deployment mechanism 103 is a two-stage system. The first stageis engagement of the pusher component 118 and the second stage isretraction of the proximal portion 109 of deployment mechanism 103 towithin the distal portion 110 of the deployment mechanism 103. Rotationof the rotating portion 110a of the distal portion 110 of the deploymentmechanism 103 sequentially engages the pusher component and then theretraction component.

In the first stage of shunt deployment, the pusher component is engagedand the pusher partially deploys the shunt from the deployment device.During the first stage, rotating portion 110 a of the distal portion 110of the deployment mechanism 103 is rotated, resulting in movement ofmembers 114 a and 114 b along first portions 113 a 1 and 113 b 1 inchannels 113 a and 113 b. Since the first portion 113 a 1 of channel 113a is straight and runs perpendicular to the length of the rotatingportion 110 a, rotation of rotating portion 110 a does not cause axialmovement of member 114 a. Without axial movement of member 114 a, thereis no retraction of the proximal portion 109 to within the distalportion 110 of the deployment mechanism 103. Since the first portion 113b 1 of channel 113 b runs diagonally along the length of the rotatingportion 110 a, upwardly toward a proximal end of the deploymentmechanism 103, rotation of rotating portion 110 a causes axial movementof member 114 b toward a proximal end of the device. Axial movement ofmember 114 b toward a proximal end of the device results in forwardadvancement of the pusher component 118 within the hollow shaft 104.Such movement of pusher component 118 results in partially deployment ofthe shunt 115 from the shaft 104.

FIGS. 11A to 11C show schematics of the deployment mechanism at the endof the first stage of deployment of the shunt from the deploymentdevice. As is shown FIG. 11A, members 114 a and 114 b have finishedtraversing along first portions 113 a 1 and 113 b 1 of channels 113 aand 113 b. Additionally, pusher component 118 has advanced within hollowshaft 104 (FIG. 11B), and shunt 115 has been partially deployed from thehollow shaft 104 (FIG. 11C). As is shown in FIG. 11C, a portion of theshunt 115 extends beyond an end of the shaft 104.

FIG. 12 shows device 100 at the end of the first stage of deployment ofthe shunt 115 from device 100 and into the eye 140. This figure showsthat the distal portion 101 b of the housing 101 remains retractedwithin the proximal portion 101 a of the housing 101, and that the shaft104 remains extended from the sleeve 130. As is shown in this figure,pusher 118 has been engaged and has partially deployed shunt 115 fromshaft 104. As is shown in this figure, a portion of the shunt 115extends beyond an end of the shaft 104 and is located in theintra-Tenon's space.

Reference is now made to FIGS. 13A to 13C. In the second stage of shuntdeployment, the retraction component of deployment mechanism is engagedand the proximal portion of the deployment mechanism is retracted towithin the distal portion of the deployment mechanism, therebycompleting deployment of the shunt from the deployment device. Duringthe second stage, rotating portion 110 a of the distal portion 110 ofthe deployment mechanism 103 is further rotated, resulting in movementof members 114 a and 114 b along second portions 113 a 2 and 113 b 2 inchannels 113 a and 113 b. Since the second portion 113 b 2 of channel113 b is straight and runs perpendicular to the length of the rotatingportion 110 a, rotation of rotating portion 110 a does not cause axialmovement of member 114 b. Without axial movement of member 114 b, thereis no further advancement of pusher 118. Since the second portion 113 a2 of channel 113 a runs diagonally along the length of the rotatingportion 110 a, downwardly toward a distal end of the deploymentmechanism 103, rotation of rotating portion 110 a causes axial movementof member 114 a toward a distal end of the device. Axial movement ofmember 114 a toward a distal end of the device results in retraction ofthe proximal portion 109 to within the distal portion 110 of thedeployment mechanism 103. Retraction of the proximal portion 109,results in retraction of the hollow shaft 104. Since the shunt 115 abutsthe pusher component 118, the shunt remains stationary at the hollowshaft 104 retracts from around the shunt 115. The shaft 104, retractscompletely to within the sleeve 130 of the distal portion 101b of thehousing 101. During both stages of the deployment process, the housing101 remains stationary and in a fixed position.

Referring to FIG. 13A, which shows a schematic of the deploymentmechanism at the end of the second stage of deployment of the shunt fromthe deployment device. As is shown in FIG. 13A, members 114 a and 114 bhave finished traversing along second portions 113 a 1 and 113 b 1 ofchannels 113 a and 113 b. Additionally, proximal portion 109 hasretracted to within distal portion 110, thus resulting in retraction ofthe hollow shaft 104 to within the housing 101.

FIG. 13B shows a schematic of the device 100 in the eye 130 after thesecond stage of deployment has been completed. FIG. 13B shows that thedistal portion 101 b of the housing 101 remains retracted within theproximal portion 101 a of the housing 101. As is shown in these FIGS.13B and 13C, shaft 104 has withdrawn through the sclera 134 and hasfully retracted to within sleeve 130. At completion of the second stageof deployment, a distal portion of the shunt 115 has been deployed andresides in the intra-Tenon's space, a middle portion of the shunt 115spans the sclera, and a proximal portion of shunt 115 has been deployedfrom shaft 104 yet still resides within sleeve 130. The proximal portionof the shunt 115 still abuts pusher 118.

Referring to FIG. 13C, in the post-deployment configuration, thedeployed indicator 119 is visible through slot 106 of the housing 101,providing feedback to the operator that the deployment mechanism 103 hasbeen fully engaged and that the deployment mechanism 103 has completedits second stage of deployment.

Referring to FIG. 14, which shows a schematic of the device 100 aftercompletion of deployment of the shunt 115 from the device 100 and in tothe eye 140. After completion of the second stage of the deployment bythe deployment mechanism 103, as indicated to the operator byvisualization of deployed indicator 119 through slot 106 of the housing101, the operator may pull the device 100 from the eye 140. Backwardforce by the operator reengages spring mechanism 120 and results inuncoiling of spring 121. Uncoiling of spring 121 proceeds as theproximal portion 101 a of housing 101 is pulled from the eye 140. Suchaction causes distal portion 101 b to return to its extended statewithin proximal portion 101 a of housing 101. Continued backward forceby the operator continues to pull the device 100 from the eye 140. Asthe device 100 is continued to be pulled from the eye, the sleeve 130 isalso pulled backward and the proximal portion of the shunt 115 isexposed from within the sleeve 130 and resides within the anteriorchamber 141 of the eye 140. The operator continues to apply backwardforce until the device 100 is completely withdrawn from the eye 140.

COMBINATIONS OF EMBODIMENTS

As will be appreciated by one skilled in the art, individual features ofthe invention may be used separately or in any combination.Particularly, it is contemplated that one or more features of theindividually described above embodiments may be combined into a singleshunt.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein.

What is claimed is:
 1. A method for treating closed angle glaucoma, themethod comprising: inserting into an eye a deployment device configuredto hold an intraocular shunt, the device comprising a sleeve with aprotrusion at a distal end of the sleeve, the protrusion (a) having agenerally linear and generally rounded distalmost edge extending in adirection transverse to the longitudinal axis of the sleeve, and (b)protruding radially outwardly, relative to a longitudinal axis of thesleeve, from a portion of the sleeve proximal to the protrusion; usingthe device to re-open an at least partially closed anterior chamberangle of an eye by moving the protrusion toward the anterior chamberangle; and advancing the shunt from the device into eye tissue while theprotrusion is in contact with tissue at the anterior chamber angle. 2.The method according to claim 1, wherein advancing the shunt comprisesforming a flow path from an anterior chamber of the eye to an area oflower pressure.
 3. The method according to claim 2, wherein the area oflower pressure is selected from the group consisting of: intra-Tenon'sspace, the subconjunctival space, the episcleral vein, thesuprachoroidal space, and Schlemm's canal.
 4. The method according toclaim 1, wherein the inserting step comprises inserting the devicethrough the cornea.
 5. The method according to claim 1, furthercomprising determining, without use of an optical apparatus thatcontacts the eye, that a distal portion of the device is at a positionat the anterior chamber angle of the eye.
 6. The method according toclaim 5, wherein the optical apparatus is a goniolens.
 7. A method fortreating closed angle glaucoma, the method comprising: inserting into aneye a deployment device (i) holding an intraocular shunt and (ii)comprising a sleeve, the sleeve comprising a wedge-shaped protrusionhaving a generally rounded edge extending transversely to a longitudinalaxis of the sleeve at a distal end of the sleeve; re-opening an at leastpartially closed anterior chamber angle of an eye, the re-openingcomprising advancing the protrusion toward an at least partially closedanterior chamber angle of the eye until the protrusion contacts tissueand then continuing advancement of the protrusion into the anteriorchamber angle without entering tissue of the eye; and after advancingthe protrusion fully into the anterior chamber angle, advancing theshunt relative to the sleeve into tissue of the eye.
 8. The methodaccording to claim 7, wherein the device further comprises a hollowshaft that is movable within the sleeve, and the method furthercomprising distally advancing the hollow shaft relative to the sleeveafter advancement of the distal portion into the anterior chamber anglewithout entering tissue of the eye.
 9. The method according to claim 7,wherein the protrusion is formed integrally with the distal end of thesleeve.
 10. The method according to claim 7, wherein the protrusionsurrounds the distal end of the sleeve.
 11. The method according toclaim 7, wherein the protrusion extends around only a portion of thesleeve.
 12. The method according to claim 7, wherein the protrusioncomprises a collar that surrounds the distal end of the sleeve.
 13. Themethod according to claim 7, wherein the protrusion comprises asubstantially flat bottom portion and a top portion that is oriented atan acute angle with respect to the bottom portion.
 14. The methodaccording to claim 7, wherein the inserting step comprises inserting thedevice through the cornea.
 15. The method according to claim 7, furthercomprising determining, without use of an optical apparatus thatcontacts the eye, that a distal portion of the device is at a positionat the anterior chamber angle of the eye.
 16. The method according toclaim 15, wherein the optical apparatus is a goniolens.
 17. A method fortreating closed angle glaucoma, the method comprising: inserting into aneye a deployment device (i) holding an intraocular shunt and (ii)comprising a sleeve, the sleeve having a lumen and a distal portioncomprising a distal end of the sleeve, the lumen having a longitudinalaxis, the distal portion comprising a wedge-shaped protrusion having alarger external dimension in a direction transverse to the longitudinalaxis than has a portion of the sleeve proximal to the distal portion;re-opening an at least partially closed anterior chamber angle of an eyeby advancing the distal portion into an at least partially closedanterior chamber angle of the eye; and with the protrusion fitted withinthe anterior chamber angle, advancing the shunt relative to the sleeveinto tissue of the eye.
 18. The method according to claim 17, whereinadvancing the shunt comprises forming a flow path from an anteriorchamber of the eye to an area of lower pressure.
 19. The methodaccording to claim 18, wherein the area of lower pressure is selectedfrom the group consisting of: intra-Tenon's space, the subconjunctivalspace, the episcleral vein, the suprachoroidal space, and Schlemm'scanal.
 20. The method according to claim 17, wherein the inserting stepcomprises inserting the device through the cornea.
 21. The methodaccording to claim 17, further comprising determining, without use of anoptical apparatus that contacts the eye, that a distal portion of thedevice is at a position at the anterior chamber angle of the eye. 22.The method according to claim 21, wherein the optical apparatus is agoniolens.
 23. The method according to claim 17, wherein the devicefurther comprises a hollow shaft that is movable within the sleeve, andthe method further comprising distally advancing the hollow shaftrelative to the sleeve after advancing the distal portion into theanterior chamber angle.
 24. The method according to claim 17, whereinthe distal portion comprises a distally facing convex surface.